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A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer

NCT01262716 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2011-10-25

No results posted yet for this study

Summary

This study will assess safety and ergonomics/engineering design of a novel cancer treatment, Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary and metastatic tumors involving the skin, in particular to improve the functionality, efficiency and wearability of the light delivery device (LDD) as well as the overall treatment in subjects with chest wall recurrences of breast cancer. An ongoing study (IRB# 8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st generation LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for subjects with chest wall recurrences of breast cancer.

A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible with the laser, delivering light to a designated region on the patient's skin.

Conditions

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Tufts Medical Center

    collaborator OTHER

  • Rogers Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • Gary S. Rogers, M.D. · Rogers Sciences Inc.

  • Roger A. Graham, M.D. · Tufts Medical Center

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01262716 on ClinicalTrials.gov